SynthesisEuropean journal of clinical pharmacology2015
Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.
Synthesis in European journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
54 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Awareness, knowledge and views of off-label prescribing in children: a systematic review.British journal of clinical pharmacology · 2015Pooled it
- A Complex Intervention to Prevent Medication-Related Hospital Admissions.Deutsches Arzteblatt international · 2023Trial
- A multi-method study of unlicensed medicine risk assessment: a cross-sectional survey of pharmacy procurement leads and policy analysis across NHS trusts in England.International journal of clinical pharmacy · 2026Article
- Antimicrobial-associated adverse events in neonates: an integrated literature review and FAERS pharmacovigilance analysis.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Potential drug-drug interactions analysis in Polish pediatric hemato-oncologic unit, including acute lymphoblastic leukemia patients.Pharmacological reports : PR · 2025Article
- Off-Label Treatment in Inflammatory Skin Diseases-European Point of View.Journal of clinical medicine · 2025Review
- Clinical and Hemodynamic Outcomes with Enalapril Orodispersible Minitablets in Young Children with Heart Failure Due to Congenital Heart Disease.Journal of clinical medicine · 2024Article
- Adverse drug reactions in paediatric surgery: prospective study on frequency and risk related factors.BMC pediatrics · 2024Observational
- Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data.Healthcare (Basel, Switzerland) · 2024Article
- Model-based exploration of the rationality of off-label use of cetirizine in Chinese pediatric patients: a prospective cohort study.Frontiers in pharmacology · 2024Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- Evaluation of off-label medication use and drug safety in a pediatric intensive care unit.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023Article
- Optimizing expert and patient input in pediatric trial design: Lessons learned and recommendations from a collaboration between conect4children and European Patient-CEntric ClinicAl TRial PLatforms.Clinical and translational science · 2023Article
- Pharmacotherapy for Children and Adolescents.Deutsches Arzteblatt international · 2023Article
- Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review.Pharmaceutics · 2023Review
- Drug Prescriptions Requiring Compounding at a Canadian University Affiliated Pediatric Hospital: A Cross-Sectional Study.Children (Basel, Switzerland) · 2023Article
- Development and performance of the c4c national clinical trial networks for optimizing pediatric trial facilitation.Frontiers in pediatrics · 2023Article
- Development, Quality by Design-Based Optimization, and Stability Assessment of Oral Liquid Formulations Containing Baclofen for Hospital Use.AAPS PharmSciTech · 2022Article
- Non-static framework for understanding adaptive designs: an ethical justification in paediatric trials.Journal of medical ethics · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of this review is to assess the extent of the use of off-label and/or unlicenced drugs among hospitalised children.
methodsA systematic search was made in MEDLINE-PubMED for papers published from 1994 to 2012, addressing the prescription of off-label and/or unlicenced drugs for the paediatric population in hospital care.
resultsOf the 829 studies retrieved, 34 met the inclusion criteria. Prescriptions ranged from 12.2 to 70.6 % for off-label and from 0.2 to 47.9 % for unlicensed drugs. The percentage of children who received at least one off-label and/or unlicensed drug ranged from 42.0 to 100 %, with newborns being the population that received most of such drugs. Off-label prescriptions were essential for dose modification (7.1-73.1 %) and unlicensed prescriptions for formulation modification purposes (3.6-100 %).
conclusionsThese findings show that: (i) off-label and/or an unlicensed prescribing is widespread among the hospitalised paediatric population worldwide, (ii) there is no consensus on a definition of off-label and/or unlicensed drugs and (iii) preterm newborns receive most off-label and/or unlicensed drugs. By shedding new light on off-label and/or unlicensed drug prescribing, these findings will hopefully contribute to generating new, more effective knowledge about the paediatric population's need for quality drugs that are both safe and efficacious.
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.